Job Description

Who we are

At Capgemini Engineering we value excellence, care, responsibility, dynamism, and innovation. We offer a job with variation that leaves plenty of room for initiative and development. Indeed, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!

Your role

• You will give quality assurance oversight (IQOQ / PQ / PV…)
• You will help define and support the Validation Approach,
• You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
• You will write and approve validation documents (GMP requirements, protocols, reports, SOPs, Critical Impact Assessments, …)
• You will make sure that production practice are aligned with validation conclusion
• You will communicate to management about issues in the validation process
• You will attend project meetings
• You will provide QA oversight and approve deviation
• You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
• You will define validation strategies through the change control process
• You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….)
• You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required
• You will support the production, QA and technical service teams in the implementation of validation activities

Your profile

• Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains,
• French or Dutch fluent and fluent in English,
• A minimum relevant experience of 3 years in the (bio)pharmaceuticals, medical devices or biotechnology sector
• Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus
• Good interpersonal relationship skills,
• Problem solving and achievement oriented,
• Be a good team player in order to succeed in each validation project,
• Be able to use a risk-based approach for problem solving and prioritization of tasks. https://tms.altran.com/jobs.cfm?offerid=23672